Status EpilepticusSENSEII/AROUSENCT05839418
Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)
An observational study of Status Epilepticus, run by Erasme University Hospital at 11 sites in 8 countries.
Trial summary
SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status Epilepticus
- How many people
- 3,000 participants
- Where
- 11 sitesin 8 countries
- Study dates
- 1 Mar 2023to 31 Dec 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients of and above 18 years admitted for Status Epilepticus management or who develop Status Epilepticus during their hospital stay
Who may be able to join
- Patients aged 18 years or above
- Patients admitted for management of Status Epilepticus as their primary diagnosis
- Patients admitted for another primary diagnosis but identified with Status Epilepticus during their acute hospital stay
Who cannot join
- Patients with post-cardiac arrest SE
Trial locations and contacts
11 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 8 countries
Austria2 sites, 2 recruiting
- Not yet recruiting
Kepler University Linz
Linz
Raimund Helbok, MD, PhD, raimund.helbok@tirol-kliniken.at
Raimund Helbok, MD, PhD
- Not yet recruiting
Christian Doppler Klinik of Paracelsus Medical University
Salzburg
Markus Leitinger, MD, PhD, ma.leitinger@salk.at
Eugen Trinka, MD, PhD, eugen@trinka.at
Germany2 sites, 2 recruiting
- Not yet recruiting
Goethe-Universität Frankfurt am Main
Frankfurt
Adam Strzelczyk, MD, strzelczyk@med.uni-frankfurt.de
Felix Rosenow, MD, Felix.Rosenow@kgu.de
- Not yet recruiting
Epilepsy Center Münster-Osnabrück, Klinikum Osnabrück
Osnabrück, D-49078
Christoph Kellinghaus, MD, Christoph.Kellinghaus@klinikum-os.de
Christoph Kellinghaus, MD
Switzerland2 sites, 2 recruiting
- Not yet recruiting
University Hospital Basel
Basel
Stephan Rueegg, MD, stephan.rueegg@usb.ch
Raoul Sutter, MD, raoul.sutter@usb.ch
- Not yet recruiting
University Hospital of Geneva
Geneva
Pia De Stefano, MD, Pia.deStefano@hcuge.ch
Pia De Stefano, MD
Belgium1 site, 1 recruiting
- Recruiting
HUB Erasme
Brussels, 1070
Nicolas Gaspard, MD, PhD, 00325553429, Nicolas.Gaspard@hubruxelles.be
Charlotte Damien, MD, 00325553429, Charlotte.Damien@hubruxelles.be
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital & Svenborg Hospital
Odense
Christoph Beier, MD, Christoph.Beier@rsyd.dk
Christop Beier, MD
Finland1 site, 1 recruiting
- Not yet recruiting
Helsinki University Central Hospital
Helsinki
Daniel Strbian, MD, Daniel.strbian@hus.fi
Leena Kampii, MD, Leena.kamppi@hus.fi
Norway1 site, 1 recruiting
- Not yet recruiting
Oslo University Hospital
Oslo
Erik Taubøll, MD, erik.tauboll@medisin.uio.no
Erik Taubøll, MD
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Birmingham University Hospitals NHS Trust
Birmingham
Maxwell Damian, MD, msdd2@cam.ac.uk
Maxwell Damian, MD
About this study
SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.
Read the detailed description
SENSE-II/AROUSE is a prospective, multicenter, non-randomized, observational registry study of consecutive cases of SE. We aimed to include university hospitals as well as non-university hospitals to enhance generalizability of the findings.
Currently, 13 high-volume medical centers in Belgium, Austria, Germany, United Kingdom, Switzerland, No common management protocol will be imposed on the participating centers. However, most institutions have established a local protocol that is closely related to the most recent guidelines for the management of SE published by the American Epilepsy Society (AES) in 2016.
We will exclude patients with anoxic status epilepticus after cardiac arrest and patients younger than 18 years.
Clinical and EEG Data will be collected prospectively from the admission of the patient to the discharge. Data collection will be performed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at Erasme Hospital in Brussels, Belgium.
To reach sufficient statistical power for multivariate analysis, a cohort size of 3000 patients is targeted.
The main objective of the study is to document patient characteristics, treatment modalities, EEG features and outcome of adults treated for SE and identify predictors of outcome. The data collected in this study could also identify gaps and opportunities for the management of this medical emergency. Lacking adequate prospective controlled trials, this will help both decision-making in clinical practice and designing future clinical trials.
Moreover, EEG data will help for a better electroencephalographic definition of SE, possible SE, and some boundary conditions, such as ictal-interictal continuum.
- Conditions
- Status Epilepticus
- Medical subject headings
- Status Epilepticus
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).
Measured: On the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Refractoriness
Refractory Status Epilepticus is defined as Status Epilepticus persisting despite administration of at least two appropriately selected and dosed parenteral medications including a benzodiazepine.
Measured: From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Secondary outcomes (3)
Modified Rankin Scale
Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).
Measured: At 30 days after the date of inclusion or SE onset (if still hospitalized)
Modified Rankin Scale
Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).
Measured: At 3 months after the date of discharge from hospital
Super-refractoriness
Super-refractory status epilepticus is defined as Status Epilepticus persisting or recurring after 24 hours or more of treatment with continuous intravenous anesthetic drugs or when therapy is tapered after 24 hours of use.
Measured: From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Gaspard, MD, PhD, Principal investigator, Erasme UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839418
- Sponsor's protocol ID
- P2020/483/B4062020000170
- Acronym
- SENSEII/AROUSE
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared with other researchers. not public upon reasonable request
Publications
Damien C, Leitinger M, Kellinghaus C, Strzelczyk A, De Stefano P, Beier CP, Sutter R, Kamppi L, Strbian D, Tauboll E, Rosenow F, Helbok R, Ruegg S, Damian M, Trinka E, Gaspard N. Sustained effort network for treatment of status epilepticus/European academy of neurology registry on adult refractory status epilepticus (SENSE-II/AROUSE). BMC Neurol. 2024 Jan 4;24(1):19. doi: 10.1186/s12883-023-03505-y.
PubMed 38178048
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)
- ClinicalTrials.gov ID
- NCT05839418
- Acronym / sponsor ID
- SENSEII/AROUSE / P2020/483/B4062020000170
- Conditions
- Status Epilepticus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.
Detailed description
SENSE-II/AROUSE is a prospective, multicenter, non-randomized, observational registry study of consecutive cases of SE. We aimed to include university hospitals as well as non-university hospitals to enhance generalizability of the findings.
Currently, 13 high-volume medical centers in Belgium, Austria, Germany, United Kingdom, Switzerland, No common management protocol will be imposed on the participating centers. However, most institutions have established a local protocol that is closely related to the most recent guidelines for the management of SE published by the American Epilepsy Society (AES) in 2016.
We will exclude patients with anoxic status epilepticus after cardiac arrest and patients younger than 18 years.
Clinical and EEG Data will be collected prospectively from the admission of the patient to the discharge. Data collection will be performed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at Erasme Hospital in Brussels, Belgium.
To reach sufficient statistical power for multivariate analysis, a cohort size of 3000 patients is targeted.
The main objective of the study is to document patient characteristics, treatment modalities, EEG features and outcome of adults treated for SE and identify predictors of outcome. The data collected in this study could also identify gaps and opportunities for the management of this medical emergency. Lacking adequate prospective controlled trials, this will help both decision-making in clinical practice and designing future clinical trials.
Moreover, EEG data will help for a better electroencephalographic definition of SE, possible SE, and some boundary conditions, such as ictal-interictal continuum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients of and above 18 years admitted for Status Epilepticus management or who develop Status Epilepticus during their hospital stay
Key inclusion criteria (3 listed)
- Patients aged 18 years or above
- Patients admitted for management of Status Epilepticus as their primary diagnosis
- Patients admitted for another primary diagnosis but identified with Status Epilepticus during their acute hospital stay
Key exclusion criteria (1 listed)
- Patients with post-cardiac arrest SE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Rankin Scale
Time frame: On the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).
Refractoriness
Time frame: From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Refractory Status Epilepticus is defined as Status Epilepticus persisting despite administration of at least two appropriately selected and dosed parenteral medications including a benzodiazepine.
3 secondary outcomes
Modified Rankin Scale
Time frame: At 30 days after the date of inclusion or SE onset (if still hospitalized)
Modified Rankin Scale
Time frame: At 3 months after the date of discharge from hospital
Super-refractoriness
Time frame: From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 38178048Damien C, Leitinger M, Kellinghaus C, Strzelczyk A, De Stefano P, Beier CP, Sutter R, Kamppi L, Strbian D, Tauboll E, Rosenow F, Helbok R, Ruegg S, Damian M, Trinka E, Gaspard N. Sustained effort network for treatment of status epilepticus/European academy of neurology registry on adult refractory status epilepticus (SENSE-II/AROUSE). BMC Neurol. 2024 Jan 4;24(1):19. doi: 10.1186/s12883-023-03505-y.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared with other researchers. not public upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas Gaspard, MD, PhD principal investigator
Erasme UH
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Status Epilepticus, run by Erasme University Hospital at 11 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Austria, Germany, Switzerland, Belgium, Denmark and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Gaspard, MD, PhD (00325553429, Nicolas.Gaspard@erasme.ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: On the date of discharge from hospital or date of death from any cause, assessed up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05839418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.